ViiV's Tivicay for HIV on course for EU approval

More positive news for GSK, Pfizer and Shionogi joint venture

ViiV Healthcare's new HIV treatment Tivicay has been recommended for approval in the EU, a few weeks after making a debut in the US.

The Committee for Medicinal Products for Human Use (CHMP) backed approval of Tivicay (dolutegravir) in combination with other antiretroviral medicines to treat adults and adolescents over 12 years of age infected with HIV.

Tivicay is an HIV integrase inhibitor and blocks replication of the virus by preventing its DNA from integrating into the genetic material of human immune cells. It is the first product launched by ViiV, which is an HIV-focused joint venture between GlaxoSmithKline, Pfizer and Shionogi.

The CHMP said Tivicay can be used in adult patients with and without resistance to the integrase class and in adolescents infected with HIV-1 without resistance to the integrase class. The positive opinion is based on safety and efficacy data for the drug from four phase III trials involving both treatment-naïve and treatment-experienced HIV patients.

Tivicay is the third entrant in the integrase inhibitor class after Merck & Co's Isentress (raltegravir) - which was first approved in 2007 - and Gilead Sciences' elvitegravir which was approved last year as part of a fixed-dose combination called Stribild that also contains cobicistat, emtricitabine and tenofovir.

It has been suggested that ViiV's drug will make strong inroads into the integrase inhibitor market because it has favourable dosing compared to Isentress (once-daily versus twice-daily), offers efficacy in patients with resistance to the class and out-performed Gilead's big-selling Atripla (efavirenz/emtricitabine/tenofovir DF) brand in the phase III SINGLE trial.

In studies Stribild was only able to demonstrate non-inferiority to Atripla, so some analysts suggest dolutegravir could be perceived as a best-in-class drug and quickly ramp up sales to $1bn or more per year.

As the first entrant, Isentress is enjoying buoyant growth, with sales up around 6 per cent year to $1.2bn in the first nine months of the year. Meanwhile, Stribild has also got off to a good start since its launch in August 2012, racking up $335m in sales in the first three quarters of 2013.

ViiV's chief medical officer John Pottage said the CHMP's positive opinion on dolutegravir puts the company "a step closer to offering the new treatment option to people across Europe who are living with HIV".

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